Metam-sodium

Endpoint summary

Description of key information

Skin irritation

The dermal irritation potential of target chemical Metam-sodium (CAS no: 137-42-8) was assessedin various experimental studies which were conducted on rabbits.Based on the available key data and supporting studies,it can be concluded thatchemical Metam-sodium (CAS no: 137-42-8) is able to cause skin irritation and considered as irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Category 2”.

 

Eye irritation

The ocular irritation potential of target chemical Metam-sodium (CAS no: 137-42-8) was assessedin various experimental studies which were conducted on rabbits.Based on the available key data and supporting studies,it can be concluded thatchemical Metam-sodium (CAS no: 137-42-8) is able to cause eye irritation and considered as irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Category 2”.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data from handbook or collection of data

Qualifier:

according to guideline

Guideline:

other: Hazardous Substances, Part 191, Section 11, FDA, Washington 1965

Principles of method if other than guideline:

A patch test was conducted for test chemical Metam-sodium (CAS no: 137-42-8) on the shaved intact or scarificed skin of six New Zealand White rabbits under occlusive condition to assess its skin irritating effects.

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material : Metam-sodium
- Common name: Sodium methyldithiocarbamate
- Molecular formula : C2H4NNaS2
- Molecular weight : 129.1826 g/mol
- Smiles notation : C(=S)(NC)[S-].[Na+]
- InChl : 1S/C2H5NS2.Na/c1-3-2(4)5;/h1H3,(H2,3,4,5);/q;+1/p-1
- Substance type: Organic
- Physical state: Solid

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

occlusive

Preparation of test site:

other: shaved intact or scarificed skin

Vehicle:

other: aqueous solution

Controls:

not specified

Amount / concentration applied:

50 %, 25 %, 12.5 % and 6.25 % aqueous preparations (0.5mL)

Duration of treatment / exposure:

24 hours

Observation period:

24, 48, 72, 96, 120, 144 and 168 hours.

Number of animals:

6 (3/sex)

Details on study design:

SCORING SYSTEM: according to DRAIZE

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

The 50 % preparation caused erythema (reaction stage 1 and partially 2 according to DRAIZE) and edema on the intact and scarificed skin throughout the observation period.

After application of the 25 % preparation 2 of 6 animals with intact skin and 5 of 6 animals with scarificed skin showed erythema and edema which still existed 144 hours after application.

The 12.5 % preparation caused erythema in 1 animal with intact skin whereas the highest dilution of the test substance was without effect in all animals.

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test material Metam-sodium (CAS no: 137-42-8) was considered to be irritating to the skin of six New Zealand White rabbits.

Executive summary:

A patch test was conducted for test chemical Metam-sodium (CAS no: 137-42-8) on six New Zealand White rabbits under occlusive condition according to Hazardous Substances, Part 191, Section 11, FDA, Washington 1965.

 

About 0.5ml of 50 %, 25 %, 12.5 % and 6.25 % aqueous preparations was applied the shaved intact or scarificed skin of each rabbits and skin reactions were read after 24, 48, 72, 96, 120, 144 and 168 hours.

 

The 50 % preparation caused erythema (reaction stage 1 and partially 2 according to DRAIZE) and edema on the intact and scarificed skin throughout the observation period. After application of the 25 % preparation 2 of 6 animals with intact skin and 5 of 6 animals with scarificed skin showed erythema and edema which still existed 144 hours after application. The 12.5 % preparation caused erythema in 1 animal with intact skin whereas the highest dilution of the test substance was without effect in all animals.

 

Hence under the test condition, the chemical Metam-sodium (CAS no: 137-42-8) was considered to be irritating to the skin of six New Zealand White rabbits.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data from handbook or collection of data

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

An eye irritation study was conducted for test chemical Metam-sodium (CAS no: 137-42-8) on the six New Zealand White rabbits to determine its eye irritational efficacy.

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of test material : Metam-sodium
- Common name: Sodium methyldithiocarbamate
- Molecular formula : C2H4NNaS2
- Molecular weight : 129.1826 g/mol
- Smiles notation : C(=S)(NC)[S-].[Na+]
- InChl : 1S/C2H5NS2.Na/c1-3-2(4)5;/h1H3,(H2,3,4,5);/q;+1/p-1
- Substance type: Organic
- Physical state: Solid

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Not specified

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

100% (Undiluted )

Duration of treatment / exposure:

96 hours

Observation period (in vivo):

after 1, 2, 4, 24, 48, 72, and 96 hours

Number of animals or in vitro replicates:

6 (3/sex)

Details on study design:

- Area of exposure: the conjunctival sac of the right eyelid

SCORING SYSTEM: according to DRAIZE

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 96 h

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Eye irritation was observed in treated rabbits.

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The test material Metam-sodium (CAS no: 137-42-8) was considered to be irritating to the eyes of six New Zealand White rabbits.

Executive summary:

An acute eye irritation study was conducted on six New Zealand White rabbits to assess the eye irritation potential of chemical Metam-sodium (CAS no: 137-42-8).

 

The undiluted chemical was instilled into the conjunctival sac of the right eyelid of 3 male and 3 female NZW-rabbits. After application the eyelids were closed for 1 second and results were read after 1, 2, 4, 24, 48, 72, and 96 hours after application according to Draize method.

 

The treated rabbits showed ocular irritation reactions, hence the test chemical Metam-sodium (CAS no: 137-42-8) was considered to be irritating to the eyes of rabbits.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

Various studieshas been investigated for the test chemicalMetam-sodium (CAS no: 137-42-8)to observe the potential for dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits for target chemicalMetam-sodium (CAS no: 137-42-8) that have beensummarized as below;

 

A patch test was conducted for test chemical Metam-sodium (CAS no: 137-42-8) on six New Zealand White rabbits under occlusive condition according to Hazardous Substances, Part 191, Section 11, FDA, Washington 1965. About 0.5ml of 50 %, 25 %, 12.5 % and 6.25 % aqueous preparations was applied the shaved intact or scarificed skin of each rabbits and skin reactions were read after 24, 48, 72, 96, 120, 144 and 168 hours. The 50 % preparation caused erythema (reaction stage 1 and partially 2 according to DRAIZE) and edema on the intact and scarificed skin throughout the observation period. After application of the 25 % preparation 2 of 6 animals with intact skin and 5 of 6 animals with scarificed skin showed erythema and edema which still existed 144 hours after application. The 12.5 % preparation caused erythema in 1 animal with intact skin whereas the highest dilution of the test substance was without effect in all animals. Hence under the test condition, the chemical Metam-sodium (CAS no: 137-42-8) was considered to be irritating to the skin of six New Zealand White rabbits.

 

The same test was conducted at 0.5ml of undiluted chemical on the shaved intact or scarificed skin of each rabbits and skin reactions were read after 24, 48, 72, 96, 120, 144 and 168 hours. The test substance caused erythema (reaction stage 1 and partially 2 according to DRAIZE) and edema on the intact and scarificed skin throughout the observation period. Hence under the test condition, the chemical Metam-sodium (CAS no: 137-42-8) was considered to be irritating to the skin of six New Zealand White rabbits.

 

In the next study, the test chemical Metam-sodium (CAS no: 137-42-8) was applied to the dorsal skin of the animals for 20 hours at concentration of 45%. After 5 days the animals showed severe suppuration at the application site. Hence the chemical Metam-sodium (CAS no: 137-42-8) was considered to be irritating to the skin of six New Zealand White rabbits.

 

Another skin irritation study was conducted on male and female rabbits for test chemical Metam-sodium (CAS no: 137-42-8). When the chemical was applied on shaved skin of each rabbit at concentration of 32.7%, the chemical caused severe skin irritation. Hence thetest materialMetam-sodium (CAS no: 137-42-8) was considered to be irritating to the rabbits’ skin.

 

When the similar stud was performed on shaved skin of each rabbit at concentration of 42%, the chemical caused moderate to severe skin irritation. Hence thetest materialMetam-sodium (CAS no: 137-42-8) was considered to be irritating to the shaved skin of male and female rabbits.

 

The skin irritation study of test chemical Metam-sodium (CAS no: 137-42-8) was conducted on intact skin of six New Zealand White rabbits to assess its irritation potential. The rabbits were exposed to metam sodium (510 g/L) at 0.5 ml and skin was semi occluded for 4 h period after which skin was washed with water. The first observation was made 30 minutes after removal of dressing and at 48 and 72 hours. Severe reactions consisting of necrotic lesions accompanied by very slight-to-slight edema were present on day 2. In two animals, the severity of response (necrosis with fissuring and associated hemorrhage) necessitated killing the animals on day 8. In 2 animals, the reactions had ameliorated slightly by day 10 but an inflammatory reaction accompanied by desquamation of stratum corneum was still present on day 14. Well-defined erythema accompanied by slight to moderate edema was observed in 2 of the remaining animals on day 1. These reactions slowly resolved and by day 10, the treatment sites were normal. Hence thetest materiaMetam-sodium (CAS no: 137-42-8) was considered to be severely irritating to the intact skin of six New Zealand White rabbits.

 

The above results were supported by the skin irritation study of test chemical Metam-sodium (CAS no: 137-42-8) on intact skin of three White Vienna rabbits (1male and 2 females) to assess its irritation potential. The rabbits were exposed to metam sodium (560 g/L) at 0.5 ml and skin was occluded for 4 h period after which skin was washed with lutrol /water. The skin reactions were scored at 24, 48 and 72 hours. Since the chemical caused skin corrosive effects on treated rabbits, thetest material materialMetam-sodium (CAS no: 137-42-8) was considered to be severely irritating to the intact skin of three White Vienna rabbits

 

The overall results were further supported by the skin irritation study conducted on albino rabbits. About 0.5 ml of test chemical was applied to the one abraded and one intact skin of each rabbit for 4 hours under occlusive condition. Skin reactions were scored upon removal of wrap at 24 and 72 hours.At 24 hours animal exhibited erythema ranging from well-defined to severe and edema ranging from moderate to severe; and at 72 hours 5/6 animals exhibited severe erythema, 1/6 animals exhibited moderate to severe erythema, 4/6animals exhibited moderate edema and 2/6 animals exhibited very slight edema. At 72 hours, 1/6 animals exhibited severe eschar formation. On day 7, all animals exhibited darkened test sites, eschar formation and superficial sloughing at test sites. Therefore the test chemicalMetam-sodium (CAS no: 137-42-8) was considered to be irritating to the albino rabbits’ skin.

 

Based on the available key data and supporting studies,it can be concluded thatchemical Metam-sodium (CAS no: 137-42-8) is able to cause skin irritation and considered as irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Category 2”.

 

 

Eye irritation:

Various studieshas been investigated for the test chemicalMetam-sodium (CAS no: 137-42-8)to observe the potential for ocular irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits for target chemicalMetam-sodium (CAS no: 137-42-8) which have beensummarized as below;

 

An acute eye irritation study was conducted on six New Zealand White rabbits to assess the eye irritation potential of chemical Metam-sodium (CAS no: 137-42-8). The undiluted chemical was instilled into the conjunctival sac of the right eyelid of 3 male and 3 female NZW-rabbits. After application the eyelids were closed for 1 second and results were read after 1, 2, 4, 24, 48, 72, and 96 hours after application according to Draize method. The treated rabbits showed ocular irritation reactions, hence the test chemical Metam-sodium (CAS no: 137-42-8) was considered to be irritating to the eyes of rabbits.

 

The same study was conducted on six New Zealand White rabbits at a dose of or 25% or 50% aqueous preparation. After application the eyelids were closed for 1 second and results were read after 1, 2, 4, 24, 48, 72, and 96 hours after application according to Draize method. The treated rabbits showed ocular irritation reactions, hence the test chemical Metam-sodium (CAS no: 137-42-8) was considered to be irritating to the eyes of rabbits.

 

 

 Another eye irritation study was conducted on male and female rabbits to assess the skin irritation potential of chemical Metam-sodium (CAS no: 137-42-8). When the chemical was instilled into the eyes of each rabbits at concentration of 32.7%, the chemical caused mild irritation. Hence thetest materialMetam-sodium (CAS no: 137-42-8) was considered to be irritating to the rabbits’ eye.

 

In next ocular irritation study, when the chemical was administrated into the eyes of each rabbit at concentration of 42%, the chemical caused slight irritation. Hence the test material Metam-sodium (CAS no: 137-42-8) was considered to be irritating be irritating to the eyes of New Zealand White rabbits.

 

The overall results were further supported by the eye irritation study conducted on nine albino rabbits. Each rabbit was examined using fluorescein dye to ensure that they were free of any ocular injury or irritation. Twenty four hours later each animal received 0.1ml of test material which was instilled in the conjunctival sac of the left eye. The treated eye of 3/9 animals was washed with water 20 to 30seconds after exposure. The untreated eye of each animal served as a control. Eye irritation was scored at 1, 24, 48 and 72 hours and at 4 and 7 days. In unwashed group, at 24 hours, conjunctiva redness (1/6) was observed and day 2, all irritation had cleared. In washed group, at 1 hour, conjunctiva redness (1/6 =2, 2/6=1), and chamois (1/6=2, 1/6=1) was observed and at 24 hours all irritation had cleared. Thus on the basis of observed effects, the test chemicalMetam-sodium (CAS no: 137-42-8) was considered to be irritating to the albino rabbits’ eyes.

 

Based on the available key data and supporting studies,it can be concluded thatchemical Metam-sodium (CAS no: 137-42-8) is able to cause eye irritation and considered as irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Category 2”.

Justification for classification or non-classification

The skin and eye irritation potential of test chemical Metam-sodium (CAS no: 137-42-8) were observed in various studies. The results obtained from these studies indicate that the chemical Metam-sodium (CAS no: 137-42-8) is likely to cause skin and eye irritation. Hence Metam-sodium (CAS no: 137-42-8) can be classified under the category “Category 2” for skin and eye as per CLP.